Drug discovery and evaluation : safety and pharmacokinetic assays /
Vogel, H. Gerhard,1927-
Maas, Jochen.
Hock, Franz J.
Mayer, D.(Dieter.)
Berlin ; New York : Springer-Verlag,
c2006.
"Springer reference"--Cover.
Includes bibliographical references and index.
Section I Safety Pharmacology: Introduction for Section I Safety Pharmacology.- Status of Safety Pharmacology and present Guidelines.- Central Nervous System Safety Pharmacology Studies.- Methods in Cardiovascular Safety Pharmacology.- Safety Pharmacology for Renal System Drugs.- Respiratory Function Assays in Safety Pharmacology.- Safety Tests in Metabolism Pharmacology.- Safety Pharmacology in Peripheral Nervous System Drugs.- Safety Pharmacology for Intravenous and Inhalation Anesthetics.- Side effects of central analgesic drugs.- Safety Pharmacology of Anti-inflammatory drugs.- Safety Pharmacology of Drugs with Osteoarthritis-related activity.- Safety Pharmacology of Blood Constituents.- Safety Assessment of Drugs Used in Ophthalmology.- Safety Assays in Endocrine Pharmacology.- Safety Assays in Skin Pharmacology.- Safety Pharmacology in Biologics.- Magnetic Resonance Imaging in Pharmaceutical Safety Assessment.- Perspectives of Safety Pharmacology, Ongoing Initiatives and Activities, Pharmaceuticals in the Environment.
Section II Safety Pharmacokinetics: Introduction.- Absorption-ex vivo tests.- Absorption-in vitro tests-cell based.- Absorption-in vitro tests-non cell based.- Absorption-in vivo tests (radiolabeled).- Bioanalytical assays-GC.- Bioanalytical assays-LC-MS/MS.- Bioanalytical assays-RIA/ELISA.- Bioanalytical assays-Toxicokinetics.- Clinical studies?typical designs.- Distribution-across barriers.- Distribution-in vitro tests-protein binding.- Distribution-in vivo-other methods.- Distribution-in vivo-perfused organs.- Distribution-in vivo-QWBA.- Drug-drug interaction-enzyme induction.- Drug-drug interaction-enzyme inhibition.- In-silico ADME Modeling.- Metabolism-enzyme mapping.- Metabolism-in vitro stability/profiling.- Metabolism-in vivo profiling.- Pharmacogenomics in DME.- Physicochemical properties.- Population kinetics.- Typical PK/PD approaches.- Section III Safety toxicology: Introduction.- International Guidelines.- General toxicity (acute, subchronic, chronic, carcinogenicity).- In silico methods.- Alternative methods for carcinogenicity testing.- Drug Addiction in monkeys.- Genotoxicity.- Pathology.- Reproductive Toxicology.- Toxicogenomics.- Toxicoproteomics.
Drug development
Pharmacology, Experimental.
Pharmacokinetics.
Drugs
Drugs